Rivaroxaban beats dalteparin in Select-D: Time for new SoC?
Cancer patients at risk for recurrent venous thromboembolism (VTE) are less likely to experience a recurrence with rivaroxaban compared with dalteparin, the Select-D trial has shown, ushering in a new standard of care (SoC) for cancer-related VTE.
Rivaroxaban is a highly selective, oral, direct factor Xa inhibitor while dalteparin is an injectable low molecular weight heparin (LMWH) approved in the UK for extended treatment and prevention of acute VTE recurrence. LMWH treatment for 6 months is considered a standard of care prior to the Select-D trial.
In the trial, VTE recurrence at 6 months was lower with rivaroxaban vs dalteparin (4 percent vs 11 percent). [ASH 2017, abstract 625]
VTE in cancer patients is an important and increasingly frequent clinical challenge, said study author Dr Annie Young from the Warwick Medical School, University of Warwick, Coventry, UK. Young and her team compared rivaroxaban (15 mg twice daily for 3 weeks, followed by 20 mg once daily for a total of 6 months) with dalteparin (200 IU/kg daily at month 1, followed by 150 IU/kg at months 2 through 6) in 406 cancer patients with VTE. Median age was 67 years, 95 percent were Caucasians.
Patients included those with an early or locally advanced disease, metastatic disease, or haematologic malignancies. Fifty-three percent had incidental pulmonary embolism and 47 percent had symptomatic lower-extremity proximal DVT. Sixty-nine percent were receiving active treatment (chemotherapy or targeted therapy) at the time of VTE.
At 6 months, patients positive for residual vein thrombosis and pulmonary embolism were randomized to placebo or rivaroxaban for another 6 months. VTE recurrence was the primary outcome, major and nonmajor bleeds (overt bleeds resulting in unscheduled contact with a physician, or discontinuation or interruption of the study drug), survival, acceptability and health economics were the secondary outcomes.
Major bleeds were similar in both groups, but the rate of clinically relevant nonmajor bleeds occurred more frequently with rivaroxaban compared with dalteparin (13 percent vs 2 percent).
Overall survival at 6 months was also similar in both groups at 70 percent (95 percent confidence interval [CI], 63–76 percent) with dalteparin and 74 percent (95 percent CI, 68–80 percent) with rivaroxaban).
“Now we have another option,” Young said. “However, my take-home message for clinicians is to have a careful discussion with their patients, to assess the risk of bleeding as well as the risk of recurrence.”
Another study, the Hokusai VTE Cancer trial, which was also presented at ASH 2017 showed that edoxaban was noninferior to dalteparin in patients with cancer-associated VTE. Recurrent VTE or severe major bleeding rates were comparable between agents, but major bleeding was higher with edoxaban.
Experts said the results of both trials may pave the way for a new standard of care for cancer-associated VTE.